WASHINGTON (dpa-AFX) - Biotechnology company Novavax, Inc. (NVAX) announced Friday that Nuvaxovid (NVX-CoV2373) has been recommended for full Marketing Authorization (MA) for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union (EU).
This authorization is based on a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The European Commission will review the CHMP recommendation and is expected to make a final decision on the MA.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as a primary series, and the immunogenicity and safety of the vaccine as a booster in individuals aged 12 and older in the Phase 3 PREVENT-19 trial, Phase 2 trials and in real-world evidence.
Novavax's COVID vaccine is authorized for use in more than 40 markets around the world. In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents, and as a booster dose in adults.
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